Patents Assigned to FDA REMS, LLC
  • Publication number: 20140249832
    Abstract: The various technologies presented herein relate to assisting a prescriber in obtaining and maintaining Risk Evaluation and Mitigation Strategy (REMS) compliance. A centralized approach is presented for obtaining REMS compliance data from a drug manufacturer, federal regulator, etc., and based on identifying one or more REMS medications associated with a prescriber, compliance of the prescriber with regard to the REMS compliance data for the one or more REMS medications can be determined. Interaction and notifications, etc., can be performed utilizing internet access. In the event of a prescriber failing a compliance requirement, one or more actions can be identified to facilitate bringing the prescriber into REMS compliance. REMS compliance data can be shared with the drug manufacturer, regulatory body, etc., to facilitate understanding of success of REMS compliance. Stored REMS compliance data can be forwarded to a third party.
    Type: Application
    Filed: March 1, 2013
    Publication date: September 4, 2014
    Applicant: FDA REMS, LLC
    Inventor: Marie Link